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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
AstraZeneca
Express Scripts
Argus Health
Medtronic
Baxter
Harvard Business School
Cipla
Queensland Health

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,889,186

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Summary for Patent: 8,889,186
Title:Modified release compositions comprising tacrolimus
Abstract: A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
Inventor(s): Holm; Per (Vanlose, DK), Norling; Tomas (Lyngby, DK)
Assignee: Veloxis Pharmaceuticals A/S (Horsholm, DE)
Application Number:14/079,466
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form; Formulation;

Drugs Protected by US Patent 8,889,186

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-001 Jul 10, 2015 RX Yes No ➤ Sign Up ➤ Sign Up PROPHYLAXIS OF ORGAN REJECTION ➤ Sign Up
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-002 Jul 10, 2015 RX Yes No ➤ Sign Up ➤ Sign Up PROPHYLAXIS OF ORGAN REJECTION ➤ Sign Up
Veloxis Pharms Inc ENVARSUS XR tacrolimus TABLET, EXTENDED RELEASE;ORAL 206406-003 Jul 10, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up PROPHYLAXIS OF ORGAN REJECTION ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted

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Non-Orange Book US Patents Family Members for Patent 8,889,186

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,161,907 Modified release compositions comprising tacrolimus ➤ Sign Up
8,623,411 Modified release compositions comprising tacrolimus ➤ Sign Up
8,586,084 Modified release compositions comprising tacrolimus ➤ Sign Up
8,591,946 Modified release compositions comprising tacrolimus ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Baxter
Boehringer Ingelheim
Chinese Patent Office
Cipla
US Department of Justice
Teva
UBS
Deloitte

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